Luer having microbore tubing retention pocket bond with axial spline

ABSTRACT

A connector is disclosed that includes comprising a body having a tubing portion, a luer portion axially opposite the tubing portion and connected thereto, and an inner circumferential surface defining an internal bore of the connector. The inner circumferential surface extends axially between the tubing portion and the luer portion, and the internal bore being is in fluid communication with the tubing portion and the luer portion. The inner circumferential surface includes a plurality of splines extending axially along a length of the inner circumferential surface in the tubing portion of the connector. The inner circumferential surface is configured to engage an external surface of a tubing in a coupled configuration. In the coupled configuration edges of the splines grip and engage the external surface of the tubing to retain the tubing in the body.

TECHNICAL FIELD

The present disclosure generally relates to medical connectors, and moreparticularly, to a medical connector having a retaining mechanism forpreventing a tubing coupled thereto from dislodging or separating fromthe connector due to the reduction of fluid in the tubing and a sealingmechanism to prevent fluid from inadvertently leaking between the tubingand connector.

BACKGROUND

In the medical field, fluids are frequently administered as infusions.The container holding the medical fluid, such as a flexible intravenous(IV) bag, is connected to an infusion device, such as an IV needle, by adisposable IV set comprising tubing having one or more fittings orconnectors. IV sets may also have intermediate ports or connectionpoints where additional fluid containers may be connected to introduceor withdraw fluid. The tubing is connected to the fittings or connectorsby one or more forms of mechanical attachment, that is inserted into theinterior of the tubing, and bonding, such as a solvent weld between aninternal pocket of the fitting and the exterior surface of the tubing.

Medical connectors are widely used in fluid delivery systems such asthose used in connection with intravenous (IV) fluid lines, bloodaccess, hemodialysis, peritoneal dialysis, enteral feeding, drug vialaccess, etc. Medical connectors may generally connect two fluid lines ortubing.

SUMMARY

The medical connector may be a hollow tubular structure that receives afluid line or tubing at one end thereof. The connector provides a flowpath for fluid entering from the tubing to exit the connector from theopposite end thereof. The presence of fluid in the tubing may create ahermetic seal between outer surface of the tubing and the inner surfaceof the medical connector. The seal may prevent the tubing fromseparating from the medical connector. However, when the fluid is absentin the tubing or when the amount of fluid in the tubing is reduced, theseal may be weakened and the tubing may be separated easily from theconnector, thereby creating a “free flow” leak.

Furthermore, where microbore tubing is used, the minimal surface area ofthe microbore tubing for bonding presents additional challenges toretaining the microbore tubing in the connector.

In accordance with various embodiments of the present disclosure, aconnector includes a body having a tubing portion, a luer portionaxially opposite the tubing portion and connected thereto, and an innercircumferential surface defining an internal bore of the connector. Theinner circumferential surface extends axially between the tubing portionand the luer portion, and the internal bore is in fluid communicationwith the tubing portion and the luer portion. The inner circumferentialsurface includes a plurality of splines extending axially along a lengthof the inner circumferential surface in the tubing portion of theconnector. The inner circumferential surface is configured to engage anexternal surface of a tubing in a coupled configuration. In the coupledconfiguration edges of the splines grip and engage the external surfaceof the tubing to retain the tubing in the body.

In accordance with various embodiments of the present disclosure, aconnector includes a body having a tubing profile, a luer profileaxially opposite the tubing portion and connected thereto, a restrictioninterposed between the luer profile and the tubing profile, and an innercircumferential surface defining an internal bore in at least the tubingprofile. The restriction includes a first end along the luer profile, asecond end along the tubing profile, and a projection extending axiallyfrom the second end, and the projection extends into the internal bore.The inner circumferential surface is configured to engage an externalsurface of a tubing in a coupled configuration. In the coupledconfiguration the projection grips the tubing to create a seal betweenthe second end of the restriction and the tubing.

BRIEF DESCRIPTION OF THE DRAWINGS

The following figures are included to illustrate certain aspects of theembodiments, and should not be viewed as exclusive embodiments. Thesubject matter disclosed is capable of considerable modifications,alterations, combinations, and equivalents in form and function, as willoccur to those skilled in the art and having the benefit of thisdisclosure.

FIG. 1 depicts a perspective view of an IV set having a medicalconnector that may employ the principles of the present disclosure, inaccordance with some embodiments of the present disclosure.

FIG. 2 is a cross-sectional view of the medical connector of FIG. 1, inaccordance with some embodiments of the present disclosure.

FIG. 3 is a partial cross-sectional view of axial splines and channelsof the tubing section of the connector of FIG. 2, in accordance withsome embodiments of the present disclosure.

FIG. 4 is an enlarged partial view of the axial splines and channels ofthe tubing section of the connector of FIG. 2, in accordance with someembodiments of the present disclosure.

FIG. 5 is a cross-sectional view of the connector of FIG. 2 including atubing inserted therein, in accordance with some embodiments of thepresent disclosure.

FIG. 6 illustrates core pins used to form the tubing profile and theluer profile on the inner circumferential surface of the connector ofFIG. 2, in accordance with some embodiments of the present disclosure.

FIG. 7 is a cutaway view of the connector (illustrated in phantom) ofFIG. 2 including the core pins of FIG. 6 disposed therein, in accordancewith some embodiments of the present disclosure.

FIG. 8 is a cross-sectional view along line 8-8 of FIG. 7, in accordancewith some embodiments of the present disclosure.

DETAILED DESCRIPTION

Various embodiments of the present disclosure are directed to providinga connector having greater tubing retention for IV sets that usemicrobore tubing which has minimal surface area for bonding.

Various embodiments of the present disclosure are additionally directedto providing connector having improved sealing capabilities so as toprevent fluid from inadvertently leaking between the external surface ofthe tubing (e.g., microbore tubing) and the internal surface of theconnector.

Embodiments disclosed are directed to a connector having a retainingmechanism for preventing a microbore tubing coupled thereto fromdislodging and/or separating from the connector in the absence (orreduction) of fluid in the tubing. Embodiments disclosed herein arefurther directed to a connector having a restriction mechanism to retainthe tubing in the connector and seal between the tubing and the innersurface of the connector. As disclosed herein, the retaining mechanismmay include a plurality of splines extending axially along an innercircumference of a tubing portion of the connector. As the fluid line(tubing) is inserted into the tubing portion, edges of the axial splinesmay dig into and grip the tubing for greater tubing retention within thetubing portion of the connector. For example, the fluid line may beinserted into the tubing portion with an interference fit whereby theouter diameter of the fluid line is slightly larger than the innerdiameter of the tubing portion. As a result, a relatively strongertensile force is required to be exerted on the tubing to separate ordislodge the tubing from the connector. Thus, accidental separation ofthe tubing may be minimized.

Further advantageously, adjacent neighboring splines define acorresponding recesses or channels therebetween similarly extendingaxially along an inner circumference of the tubing portion of theconnector. As such, an increased amount of solvent for bonding the fluidline or tubing to the tubing portion may be collected into the channelsfor maximum boding. This will insure a uniform spread of solvent andeliminate possible squeegee of fluid on the bonding surface. This is incontrast to conventional connector and fluid line bonding techniqueswhere the solvent is flowed into the connector and once the tubing isinserted into the connector, the solvent is subject to squeegee by thetubing, thereby reducing surface area of the solvent between the tubingand the connector for bonding.

As disclosed herein, the restraining mechanism may include radialprojections, sealing rings, or alternatively barbed fittings, barbededges, or similar structures that may retain the tubing. The restrictionmechanism ensures that a seal is maintained between the tubing and theinner surface of the connector during low pressure conditions (e.g.,during the absence of fluid in the tubing) since there is aninterference fit between the tubing and the connector. As a result, arelatively stronger tensile force is required to be exerted on thetubing to separate or dislodge the tubing from the connector. Thus,accidental separation of the tubing is minimized.

In some embodiments, the restriction mechanism may include one or moreradial projections or ledges on an internal surface of the connectorthat limits the extent of the tubing in the connector when insertedtherein. As discussed below, the connector at the end opposite to theend receiving the tubing may include a female luer fitting. Therestriction mechanism prevents the tubing from extending into the femaleluer fitting during assembly and thereby ensures correct operation ofthe medical connector.

Another advantage of the medical connector, according to embodimentsdisclosed, is that there is not a substantial increase in themanufacturing costs of the medical connector. Existing manufacturingequipment may be modified at minimal costs to manufacture the examplemedical connector. For example, the core pins of the injection moldingequipment used to manufacture the medical connector may be redesigned tocreate the axial splines and channels, and the restraining mechanisms.

As used herein, the terms “tubing,” “fluid line,” and any variationthereof refers to medical lines or tubes used to deliver liquids,solvents, or fluids (including gas) to or from a patient under medicalcare. For example, fluid lines (tubing) may be used for intravenous (IV)delivery of fluids, fluid drainage, oxygen delivery, a combinationthereof, and the like.

As used herein, the terms “medical connector,” “connector,” “fitting,”and any variation thereof refer to any device used to provide a fluidflow path between two or more fluid lines coupled thereto. For example,the medical connector may be or include a bond pocket or other types ofconnectors.

FIG. 1 depicts a perspective view of an IV set 10 having a medicalconnector 100 that may employ the principles of the present disclosure,in accordance with some embodiments of the present disclosure. Asdepicted, the IV set may include a fluid source such as a fluid bag 2which may include or contain saline solution or other fluid to beadministered to a patient. As illustrated, a first tubing 6 carries flowfrom a drip chamber 4, through connector 100, and into a second fluidline or tubing 170. An IV pump (not shown) receives fluid from fluidsystem 2 via second tubing 170, and controls and dispenses the fluidstherefrom to a patient. As shall be described in further detail below, atubular portion of the connector 100 has an internal bore configured toreceive the second tubing 170. For the purposes of the presentdisclosure, the second tubing 170 will be described as microbore orsmallbore tubing, and the connector 100 will thus be described as beingconfigured to receive and retain microbore tubing. However, the variousembodiments of the connector described herein may be applied to othertypes of tubing, e.g. macrobore or largebore tubing.

FIG. 2 illustrates a cross-sectional view of the medical connector 100of FIG. 1, according to embodiments disclosed. As illustrated, themedical connector 100 (or simply, connector) may include a generallycylindrical body 101 having a “first” or tubing portion 103 and a“second” or luer portion 105 axially opposite the tubing portion 103 andconnected thereto. In some embodiments, the body 101 may also include agrip 107 disposed along the outer surface of the body 101. The tubingportion 103 may include a tubing port 120 that is sized and shaped orotherwise configured to receive a fluid line (referred to hereafter as“tubing”), as discussed below. Similarly, the luer portion 105 mayinclude a luer port 125 that is sized and shaped or otherwise configuredto receive a male luer connector. As depicted, the body 101 defines aninternal longitudinal passageway or bore 140 extending from the tubingport 120 to the luer port 125 and fluidly connecting the tubing port 120and the luer port 125 with each other.

In the depicted embodiments, the internal bore 140 is defined by theinner circumferential surface 112 of the body 101 and is continuous fromthe tubing port 120 to the luer port 125. In some embodiments, the innercircumferential surface 112 in the tubing portion 103 and the luerportion 105 has two non-similar profiles. Specifically, the innercircumferential surface 112 in the tubing portion 103 has a tubingprofile 135 and the inner circumferential surface 112 in the luerportion 105 has a luer profile 133. The tubing profile 135, and therebythe tubing portion 103 of the connector 100, is sized and shaped (orotherwise configured) to receive a tubing. In particular, the tubingprofile 135 may be sized, shaped, and otherwise configured to receive amicrobore tubing 170 (described in further detail below). For example,tubing having an inner diameter of less than 0.100 inches, andparticularly tubing having an outer diameter of approximately 0.079inches or less, is considered “smallbore” or “microbore” and is bondedinto a tubing pocket such as the internal bore 140 defined in tubingprofile 135. Tubing having an inner diameter of greater than 0.100inches is typically considered “macrobore.” Exemplary embodiments of thepresent disclosure are illustrated and described herein with respect toa tubing that is in the form of a “smallbore” or “microbore” tubing anda pocket bond for a “smallbore” or “microbore” tubing. However, thevarious embodiments of the present disclosure are not limited to theaforementioned configuration and may similarly be applied to “largebore”or “macrobore” tubing and related connectors, as well as any otherintermediate size tubings and connectors between “microbore” and“macrobore” connectors. The luer profile 133, and thereby the luerportion 105 of the connector 100, may be sized and shaped (or otherwiseconfigured) to receive male luer fittings. The luer profile 133, andthereby the luer portion 105, may be ISO-594 compliant.

During assembly, in order to limit the extent of the tubing inserted,advanced, or otherwise “slipped” into the connector 100, the innercircumferential surface 112 may include a restriction mechanism(hereafter referred to as “restriction 130”). The restriction 130 may bedefined to protrude radially inward from the inner circumferentialsurface 112, and may be interposed between the luer profile 133 and thetubing profile 135. In some embodiments, the restriction 130 serves as astop for the insertion of tubing into the internal bore 140 defined inthe luer profile 133. Accordingly, restriction 130 may have a diameterD2 (illustrated in FIG. 6) that is smaller than the smallest diameter D1of the internal bore 140 defined in the tubing profile 135.

In accordance with some embodiments, the tubing profile 135 of thetubing portion 103 may include a retaining mechanism for improving theability of the connector 100 to retain the microbore tubing 170 insertedtherein and thereby prevent the microbore tubing 170 from separating (orotherwise dislodging) from the connector 100. For example, the retainingmechanism may prevent the microbore tubing 170 from separating (orotherwise dislodging) from the connector 100 during a low pressurecondition in the tubing created due to a reduction in the fluid in thetubing. In an example, and as illustrated, the retaining mechanism maybe or include a plurality of splines 115 extending linearly along alength of the inner circumferential surface 112 of the tubing portion103 of connector 100. As the microbore tubing 170 (illustrated in FIG.5) is inserted into the tubing portion 103 of the connector 100, innercircumferential surface 112 in the tubing portion 103 is configured toengage an external surface of the microbore tubing 170 in a coupledconfiguration. For example, as the microbore tubing 170 is inserted intothe tubing portion 103, edges 137 of the axial splines 115 may dig intoand grip the exterior surface of the tubing for greater tubing retentionwithin the tubing portion of the connector. Thus, in the coupledconfiguration, the microbore tubing 170 may be inserted into the tubingportion with an interference fit such that edges 137 of the axialsplines 115 dig into, grip and engage the external surface of themicrobore tubing 170 to retain the microbore tubing 170 in the tubingportion 103 of the connector 100. The aforementioned configurationprovides the advantage that once the edges 137 of the axial splines 115dig into, grip and engage the external surface of the microbore tubing170, friction between the microbore tubing 170 and inner circumferentialsurface 112 is increased such that the microbore tubing 170 may not beeasily dislodged from the connector 100, without departing from thescope of the disclosure. For example, by biting or digging into theexternal surface of the microbore tubing 170, the axial splines mayincrease the friction between the connector 100 and the microbore tubing170 when a tensile force (direction indicated by the arrow F,illustrated in FIG. 5) is applied on the microbore tubing 170 to removeit from the connector 100. Advantageously as a result, the tensile forcerequired to remove or otherwise dislodge the microbore tubing 170 fromthe connector 100 is increased and thus the microbore tubing 170 isbetter secured and retained in the connector 100. Further, fluid in themicrobore tubing 170 may exert pressure in a radially outward direction,which may further increase the friction between the microbore tubing 170and the inner circumferential surface 112.

In accordance with some embodiments, adjacent neighboring splines 115define corresponding recesses or channels 145 therebetween. The channels145 similarly extend axially along the inner circumferential surface 112of the tubing portion 103 of connector 100. Advantageously, an increasedamount of solvent for bonding the microbore tubing 170 to the innercircumferential surface 112 defined in the tubing portion 103 may becollected into the channels 145 for maximum bonding. In particular,collecting the solvent in the channels 145 allows for an increasedamount of solvent available for bonding of the microbore tubing 170 tothe inner circumferential surface 112 of the tubing portion 103.Providing the channels 145 with the solvent collected therein will yielda uniform spread of solvent and eliminate possible squeegee of fluid onthe bonding surface of the tubing portion 103. Thus, a maximum amount ofsolvent remains available for bonding the microbore tubing 170 to theinner circumferential surface 112 of the tubing portion 103, and an evengreater tubing retention may be achieved. This is in contrast toconventional connector and tubing bonding techniques where the solventis flowed into the connector and once the fluid line/tubing is insertedinto the connector, the solvent is subject to squeegee by the tubing,thereby reducing surface area of the solvent between the tubing and theconnector.

FIG. 3 is a partial cross-sectional view of axial splines and channelsof the tubing section of the connector of FIG. 2, in accordance withsome embodiments of the present disclosure. FIG. 4 is an enlargedpartial view of the axial splines and channels of the tubing section ofthe connector of FIG. 2, in accordance with some embodiments of thepresent disclosure.

Referring to FIGS. 3 and 4, with continued reference to FIG. 2, each ofthe axial splines may be defined by a first inclined surface 117, asecond inclined surface 119 and the edge 137 interposed between thefirst and second inclined surface 117 and 119. As depicted, the axialsplines may be formed in the shape of teeth of a spline gear. Since thechannels 145 are defined between adjacent splines 115, each of thechannels 145 are defined by adjacent first and second inclined surfaces117 and 119 meeting at a vertex 121. However, the shapes of the axialsplines 115 and channels 145 is not limited to the aforementionedconfiguration. For example, the axial splines 115 and channels 145 maynot be restricted to any particular shape or size as long as the axialsplines 115 have a shape so as to “bite into,” “dig into,” grip, orotherwise engage the outer surface of the microbore tubing 170, and aslong as the channels 145 form a recess of sufficient depth to contain asolvent therewithin.

In accordance with some embodiments, the axial splines 115 and channels145 may be disposed at regular intervals along the inner circumferentialsurface 112 of the tubing portion 103. However, in other embodiments,the axial splines 115 and channels 145 may be disposed at irregularintervals along the inner circumferential surface 112 of the tubingprofile 135.

In accordance with some embodiments, an angle α between the firstinclined side 117 and the second inclined side 119 of adjacent splinesranges from about 30 degrees to 150 degrees, more typically about 60degrees to 120 degrees, 80 degrees to 100 degrees, or in some casesapproximately 90 degrees. Though recited in terms of certain ranges, itwill be understood that all ranges from the lowest of the lower limitsto the highest of the upper limits are included, including allintermediate ranges or specific angles, within this full range or anyspecifically recited range.

In some embodiments, a height of each of the splines as measured fromthe vertex 121 to the edge 137 of each spline may range from about0.0001 inches to 0.002 inches, more typically about 0.0005 inches to0.00195 inches, 0.001 inches to 0.002 inches, or in some casesapproximately 0.0015 inches. Accordingly, a depth of each of thechannels 145 defined by adjacent splines 115 may range from about 0.0001inches to 0.002 inches, more typically about 0.0005 inches to 0.00195inches, 0.001 inches to 0.002 inches, or in some cases approximately0.0015 inches. Though recited in terms of certain ranges, it will beunderstood that all ranges from the lowest of the lower limits to thehighest of the upper limits are included, including all intermediateranges or specific dimensions, within this full range or anyspecifically recited range.

In some embodiments, the depth of each of the channels tapers in adirection towards the tubing port 120. For example, each of the channels145 may have a maximum depth in the region adjacent to a second end 155of the restriction 130. As the channels 145 approach the tubing port120, the depth of each of the channels 145 may progressively decreaseuntil each channel 145 terminates.

Referring back to FIG. 2, a length of each of the axial splines 115spans a portion of the length of the inner circumferential surface 112of the tubing portion 103. In some embodiments, the length of the axialsplines 115 spans between about 10% and 90% of the length of the innercircumferential surface 112 of the tubing portion 103, more typicallybetween about 25% and 75%, between about 40% and 60%, or in some casesapproximately 50% of the length of the inner circumferential surface 112of the tubing portion 103. Since the channels 145 are defined betweenadjacent axial splines 115, the length of each of the channels 145similarly may spans between about 10% and 90% of the length of the innercircumferential surface 112 of the tubing portion 103, more typicallybetween about 25% and 75%, between about 40% and 60%, or in some casesapproximately 50% of the length of the inner circumferential surface 112of the tubing portion 103. Though recited in terms of certain ranges, itwill be understood that all ranges from the lowest of the lower limitsto the highest of the upper limits are included, including allintermediate ranges or specific percentages, within this full range orany specifically recited ranges. It is advantageous to ensure that thechannels do not extend all the way through the tubing port in order toprevent inadvertent fluid leaks, as well as to prevent solvent frominadvertently leaking out of the tubing portion 103.

FIG. 5 is a cross-sectional view of the connector 100 of FIG. 2including the microbore tubing 170 inserted therein, in accordance withsome embodiments of the present disclosure. As previously described, theconnector 100 may include a restriction 130. As illustrated in FIG. 5,the restriction 130 may include a first end 150 defined along the luerprofile 133 and a second end 155 defined along the tubing profile 135.In the depicted embodiments, the second end 155 may include a radialprojection 160 protruding (or otherwise projecting) radially inward andat an angle from the inner circumferential surface 112 of the tubingprofile 135. The radial projection 160 may be configured to dig into,grip, or otherwise engage a first end of the microbore tubing 170 tocreate a seal between the second surface end 155 of the restriction 130and the microbore tubing 170 to prevent fluid from inadvertently leakingbetween the external surface 172 of the microbore tubing 170 and theinner circumferential surface 112 defined in the tubing portion 103. Insome embodiments, the radial projection 160 is circularly disposed abouta central axis X1 of the internal bore 140.

The radial projection 160 may form a sealing ring that prevents fluidfrom inadvertently leaking between the outer surface of the microboretubing 170 and the inner circumferential surface 112 defined in thetubing portion 103. In some embodiments, the radial projection 160 maybe formed with an undercut so as to sufficiently “bite into” orotherwise engage the first end of the microbore tubing 170.

In some embodiments, a maximum distance by which the radial projection160 projects into the internal bore 140 is less than or equal to thethickness of the microbore tubing 170. This prevents the radialprojection 160 from occluding the fluid travelling the tubing insertedinto the connector 100. The restriction 130 may not be restricted to anyparticular shape or size as long as the restriction 130 prevents theextent of the tubing inserted into the connector 100.

Thus, in some embodiments, the radial projection 160 may also act as aretaining mechanism for improving the ability of the connector 100 toretain the microbore tubing 170 inserted therein and thereby prevent themicrobore tubing 170 from separating (or otherwise dislodging) from theconnector 100, for example, during a low pressure condition in thetubing created due to a reduction in the fluid in the tubing. In anexample, and as illustrated, the radial projection 160 may be disposedat or adjacent the boundary between the tubing portion and the luerportion 105. As depicted, the radial projection 160 may project radiallyinward a certain distance from the inner circumferential surface 112into the internal bore 140 defined in the tubing portion 103. In anexample, the radial projection 160 may be a spike like structure thatextends from the inner circumferential surface 112.

Advantageously, the radial projection 160 may thus be a structure thatincreases friction between the outer surface of the microbore tubing 170and the inner circumferential surface 112 such that the microbore tubing170 may not be easily dislodged from the connector 100, withoutdeparting from the scope of the disclosure. In some embodiments, theradial projection 160 may be structured as a ramp that has a slightundercut configured to slightly compress the microbore tubing 170 as itis inserted or advanced into the connector 100. When the microboretubing 170 is pulled to be withdrawn from the connector, the top of theramp, and in some embodiments the undercut portion, will secure themicrobore tubing 170 within the connector 100 as illustrated in FIG. 5.In some embodiments, the top of the ramp, or the undercut portion, willdig into or grip the microbore tubing 170 when it is attempted to bewithdrawn from within the connector 100, as explained further below.

Referring to FIG. 5, with continued reference to FIG. 2, the microboretubing 170 may be inserted into the connector 100 generally in thedirection of arrow A and the radial projection 160 may have a tapereddistal end 162 that is generally oriented in the direction in which themicrobore tubing 170 is inserted into the connector 100. The microboretubing 170 may be inserted into the connector 100 with relative ease.However, the radial projection 160 may increase the friction between theconnector 100 and the microbore tubing 170 when a tensile force(direction indicated by the arrow F) is applied on the microbore tubing170 to remove it from the connector 100. Advantageously as a result, thetensile force required to remove or otherwise dislodge the microboretubing 170 from the connector 100 is increased and thus the microboretubing 170 is better secured in the connector 100. Further, fluid in themicrobore tubing 170 may exert pressure in a radially outward direction,which may further increase the friction between the microbore tubing 170and the radial projection 160.

It should be noted that the locations of the radial projection on theinner circumferential surface 112 in the Figures are merely examples,and the location may be changed, without departing from the scope of thedisclosure. Further, although the Figures indicate one radialprojection, the radial projection may be replaced, for example withledges and/or barbed features, the number of which may not be limitedand may be increased or decreased, without departing from the scope ofthe disclosure. For example, multiple ledges may be disposed at regularintervals along the inner circumferential surface 112 in the tubingportion 103. However, in other embodiments, the ledges may be disposedat irregular intervals along the inner circumferential surface 112.Similarly, multiple barbed features may be disposed at regular intervalsalong the inner circumferential surface 112 in the tubing portion 103.However, in other embodiments, the barbed features may be disposed atirregular intervals. The circumferential extent of barbed features maybe around a quarter of a quadrant of the inner circumferential surface112. However, in other examples, the circumferential extent of thebarbed features may be increased or decreased as required by applicationor design, and without departing from the scope of the disclosure.

FIG. 6 illustrates core pins 201 and 203 used to respectively form thetubing profile 135 and the luer profile 133 on the inner circumferentialsurface 112 of the connector 100 of FIG. 2, in accordance with someembodiments of the present disclosure. In accordance with someembodiments, the connector 100 may be manufactured using an injectionmolding process. However, other manufacturing processes may also be usedto manufacture the connector 100, without departing from the scope ofthe disclosure. In an example, the core pin 201 may form the luerprofile 133 of the inner circumferential surface 112 and the core pin203 may form the tubing profile 135 of the inner circumferential surface112. For the sake of brevity, the processing steps and molds used forcreating the features (e.g., grip 107) on the outer surface of the body101 are omitted.

As depicted, core pin 201 has a generally elongated body 202 having aluer-shaping portion 206 and a restriction-shaping portion 208. Theluer-shaping portion 206 has a generally cylindrical outer surface 212having a diameter larger than the diameter of the restriction-shapingportion 208. The outer surface 212 of the luer-shaping portion 206 isshaped to form the luer profile 133 (illustrated in FIG. 2). Arestriction-forming profile 210 may be formed on the outer surface 212proximate a distal end 218 of the luer-shaping portion 206.

In accordance with some embodiments, the core pin 203 also has agenerally elongated body 222 having base portion 225 with a cylindricalouter surface 226 and a tubing-shaping portion 220 having a cylindricalouter surface 222. In some embodiments, the diameter D4 of the baseportion 225 is greater than the diameter D3 of the tubing-shapingportion 220. The cylindrical outer surface 222 is shaped and sized toform the tubing profile 135 (FIG. 2) of the tubing portion 103. In thedepicted embodiments, the cylindrical outer surface 222 of thetubing-shaping portion 220 may be formed with a plurality of axiallyextending teeth 224 formed along a radial exterior of the outer surface222. Adjacent teeth 224 may define a recess 215 therebetween. As shallbe described below, during manufacturing, the teeth 224 define a shapeof the channels 145 and the recesses 215 define a shape of the axialsplines 115 of the connector.

In the depicted embodiments, the length of each of the axially extendingteeth 224 may span a portion of the length of the inner circumferentialsurface 112 of the tubing portion 103. In some embodiments, the lengthof the axially extending teeth 224 spans between about 10% and 90% ofthe length of the inner circumferential surface 112 of the tubingportion 103, more typically between about 25% and 75%, between about 40%and 60%, or in some cases approximately 50% of the length of the innercircumferential surface 112 of the tubing portion 103. Since therecesses 215 are defined between adjacent axially extending teeth 224,the length of each of the recesses similarly may span between about 10%and 90% of the length of the inner circumferential surface 112 of thetubing portion 103, more typically between about 25% and 75%, betweenabout 40% and 60%, or in some cases approximately 50% of the length ofthe inner circumferential surface 112 of the tubing portion 103. Thoughrecited in terms of certain ranges, it will be understood that allranges from the lowest of the lower limits to the highest of the upperlimits are included, including all intermediate ranges or specificpercentages, within this full range or any specifically recited ranges.

FIG. 7 is a cutaway view of the connector (illustrated in phantom) ofFIG. 2 including the core pins 201 and 203 of FIG. 6 disposed therein,in accordance with some embodiments of the present disclosure. FIG. 8 isa cross-sectional view of the connector 100 and core pin 203 taken alongline 8-8 of FIG. 7, in accordance with some embodiments of the presentdisclosure. In accordance with some embodiments, the connector 100 maybe manufactured using an injection molding process. The connector 100may be made of plastic or similar material that can be molded into adesired shape. An external mold (not illustrated) may be used to createthe external features of the connector 100. These external features mayinclude the grip 107, and the outer surface of the cylindrical body 101.The internal bore 140, tubing profile 135, the luer profile 133, therestriction 130, and the radial projection 160 may be formed using thecore pins 201 and 203.

During manufacture, material forming the connector 100 may be placed ina molding tool including the core pins 201 and 203 axially aligned witheach other. The core pins 201 and 203 may be brought together fromaxially opposite ends into the material. The material may be in asemi-solid, malleable state in order to mold it into a desired shape.The core pins 201 and 203 may be brought towards each other until thecore pins 201 and 203 couple to each other, as illustrated in FIG. 7.

Referring back to FIG. 6, the distal end 219 of the tubing-shapingportion 220 of the core pin 203 may include radial projection-formingprofile 228 including formed as a ring having an inner surface 229angled radially inward and a cavity 230 defined therethrough. When thecore pins 201 and 203 are coupled to each other, the distal end 218 ofthe core pin 201 is received partially into the cavity 230 defined bythe radial projection-forming profile 228. In particular, as depicted,the distal end 218 of the core pin 201 is disposed concentrically with,and radially interior to the inner surface 229 of the radialprojection-forming profile 228. The restriction-shaping portion 208 andthe radial projection-forming profile 228 cooperatively form therestriction 130 and the radial projection. Specifically, when the corepins 201 and 203 are coupled to each other, a void is formed between therestriction-shaping portion 208 and the radial projection-formingprofile 228. The void is filled with the semi-solid, malleable connectormaterial and molded into the shape of the void (i.e. the shape of theradial projection 160).

Furthermore, during manufacture, when the core pins 201 and 203 arecoupled to each other and the semi-solid, malleable connector materialis placed in the molding tool including the core pins 201 and 203axially aligned with each other, the axially extending teeth 224 maypierce into the semi-solid, malleable connector material and form animprint therein. The semi-solid, malleable connector material may alsofill the recesses 215 and be molded into a shape defined by the recesses215. Once the semi-solid, malleable connector material has solidified,the core pins 201 and 203 are removed. When the core pin 203 is removedaxially extending recesses are created along the inner circumferentialsurface 112 of the tubing portion 103 where the axially extending teeth224 pierced into the connector material. The axially extending channelscorrespond to the axially extending channels 145 in the tubing profile135 of the tubing portion 103. Similarly, when the core pin 203 isremoved axially extending splines project along the innercircumferential surface 112 of the tubing portion 103 where thesemi-solid, malleable connector material filled the recesses 215. Thefilled recesses 215 correspond to the axial splines 115 formed on thetubing profile 135 of the tubing portion 103.

As previously described, in some embodiments, the depth of each of thechannels 145 tapers in a direction towards the tubing port 120. Thetapering of the depth of each of the channels 145 is due to theconfiguration of the tubing profile 135. For example, as depicted, thediameter D1 of the internal bore 140 at the end of the tubing profile135 adjacent to the restriction 130 is smaller than the diameter D2 ofinternal bore 140 at the end of the tubing profile 135 adjacent to thetubing port 120. As such, the tubing profile 135 tapers in a directionfrom the end adjacent to the tubing port 120 to the end adjacent to therestriction 130. When the core pin 203 having the axially extendingteeth 224 is positioned in the mold with the material used to form theconnector 100, the teeth 224 dig deeper into the connector material inthe area of the tubing profile adjacent to the restriction 130 (due tothe smaller diameter D1) and dig progressively less into the connectormaterial in the direction of the tubing port 120 (due to the diameterincreasing to D2 in the direction of the tubing port). Since the teeth224 dig deeper into the connector material in the area of the tubingprofile 135 adjacent to the restriction 130, the resulting channels 145have a greater depth and the resulting axial splines have a greaterheight in this area than in the area approaching the tubing port 120.

The aforementioned configuration is advantageous in that axial splines115 are able to bite into or grip the microbore tubing 170 to a greaterdegree in the area of the tubing profile adjacent to the restriction130, thereby necessitating a relatively stronger tensile force to beexerted on the microbore tubing 170 to separate or dislodge themicrobore tubing 170 from the connector 100. Thus, accidental separationof the microbore tubing 170 from the connector 100 may be minimized.

In accordance with some embodiments, the axial splines 115 and channels145 may be disposed at regular intervals along the inner circumferentialsurface 112 of the tubing portion 103. However, in other embodiments,the axial splines 115 and channels 145 may be disposed at irregularintervals along the inner circumferential surface 112 of the tubingprofile 135.

In accordance with some embodiments, an angle α between the firstinclined side 117 and the second inclined side 119 of adjacent splinesranges from about 30 degrees to 150 degrees, more typically about 60degrees to 120 degrees, and 80 degrees to 100 degrees, or in some casesapproximately 90 degrees. Though recited in terms of certain ranges, itwill be understood that all ranges from the lowest of the lower limitsto the highest of the upper limits are included, including allintermediate ranges or specific angles, within this full range or anyspecifically recited range.

In some embodiments, similar to the axial splines 115, a depth of eachof the recesses 215 may range from about 0.0001 inches to 0.002 inches,more typically about 0.0005 inches to 0.00195 inches, 0.001 inches to0.002 inches, or in some cases approximately 0.0015 inches. Accordingly,similar to the axial channels 145, a height H of each of the axiallyextending teeth 224 may range from about 0.0001 inches to 0.002 inches,more typically about 0.0005 inches to 0.00195 inches, 0.001 inches to0.002 inches, or in some cases approximately 0.0015 inches. Thoughrecited in terms of certain ranges, it will be understood that allranges from the lowest of the lower limits to the highest of the upperlimits are included, including all intermediate ranges or specificdimensions, within this full range or any specifically recited range.

The previous description is provided to enable any person skilled in theart to practice the various aspects described herein. While theforegoing has described what are considered to be the best mode and/orother examples, it is understood that various modifications to theseaspects will be readily apparent to those skilled in the art, and thegeneric principles defined herein may be applied to other aspects. Thus,the claims are not intended to be limited to the aspects shown herein,but is to be accorded the full scope consistent with the languageclaims, wherein reference to an element in the singular is not intendedto mean “one and only one” unless specifically so stated, but rather“one or more.” Unless specifically stated otherwise, the terms “a set”and “some” refer to one or more. Pronouns in the masculine (e.g., his)include the feminine and neuter gender (e.g., her and its) and viceversa. Headings and subheadings, if any, are used for convenience onlyand do not limit the invention.

It is understood that the specific order or hierarchy of steps in theprocesses disclosed is an illustration of exemplary approaches. Basedupon design preferences, it is understood that the specific order orhierarchy of steps in the processes may be rearranged. Some of the stepsmay be performed simultaneously. The accompanying method claims presentelements of the various steps in a sample order, and are not meant to belimited to the specific order or hierarchy presented.

Terms such as “top,” “bottom,” “front,” “rear” and the like as used inthis disclosure should be understood as referring to an arbitrary frameof reference, rather than to the ordinary gravitational frame ofreference. Thus, a top surface, a bottom surface, a front surface, and arear surface may extend upwardly, downwardly, diagonally, orhorizontally in a gravitational frame of reference.

A phrase such as an “aspect” does not imply that such aspect isessential to the subject technology or that such aspect applies to allconfigurations of the subject technology. A disclosure relating to anaspect may apply to all configurations, or one or more configurations. Aphrase such as an aspect may refer to one or more aspects and viceversa. A phrase such as an “embodiment” does not imply that suchembodiment is essential to the subject technology or that suchembodiment applies to all configurations of the subject technology. Adisclosure relating to an embodiment may apply to all embodiments, orone or more embodiments. A phrase such an embodiment may refer to one ormore embodiments and vice versa.

The word “exemplary” is used herein to mean “serving as an example orillustration.” Any aspect or design described herein as “exemplary” isnot necessarily to be construed as preferred or advantageous over otheraspects or designs.

All structural and functional equivalents to the elements of the variousaspects described throughout this disclosure that are known or latercome to be known to those of ordinary skill in the art are expresslyincorporated herein by reference and are intended to be encompassed bythe claims. Moreover, nothing disclosed herein is intended to bededicated to the public regardless of whether such disclosure isexplicitly recited in the claims. No claim element is to be construedunder the provisions of 35 U.S.C. § 112, sixth paragraph, unless theelement is expressly recited using the phrase “means for” or, in thecase of a method claim, the element is recited using the phrase “stepfor.” Furthermore, to the extent that the term “include,” “have,” or thelike is used in the description or the claims, such term is intended tobe inclusive in a manner similar to the term “comprise” as “comprise” isinterpreted when employed as a transitional word in a claim.

What is claimed is:
 1. A connector comprising: a body having a tubingportion, a luer portion axially opposite the tubing portion andconnected thereto; and an inner circumferential surface defining aninternal bore of the connector, the inner circumferential surfaceextending axially between the tubing portion and the luer portion andthe internal bore being in fluid communication with the tubing portionand the luer portion, wherein, the inner circumferential surfacecomprises a plurality of splines extending linearly along a length ofthe inner circumferential surface in the tubing portion of the connectorand each pair of adjacent splines of the plurality of splines define achannel therebetween and a depth of each of the channels tapers in adirection towards a port of the tubing portion, and wherein: the innercircumferential surface is configured to engage an external surface of atubing in a coupled configuration; and in the coupled configuration,edges of the plurality of splines grip and engage the external surfaceof the tubing to retain the tubing in the body.
 2. The connector ofclaim 1, wherein each of the channels comprising a recess extendingaxially along a length of the inner circumferential surface.
 3. Theconnector of claim 2, wherein a height of each spline of the pluralityof splines ranges from about 0.0001 inches to 0.002 inches.
 4. Theconnector of claim 2, wherein an angle between sides of adjacent splinesof the plurality of splines ranges from about 30 degrees to 150 degrees.5. The connector of claim 2, wherein the tubing comprises microboretubing.
 6. The connector of claim 2, wherein the plurality of splinesare equally spaced apart from each other about the inner circumferentialsurface of the tubing portion.
 7. The connector of claim 2, wherein alength of each spline of the plurality of splines spans a portion of thelength of the inner circumferential surface of the tubing portion. 8.The connector of claim 7, wherein the length of each spline of theplurality of splines spans half or less of the length of the innercircumferential surface.
 9. The connector of claim 2, wherein therecesses have a depth ranging from about 0.0001 inches to 0.002 inches.10. The connector of claim 2, wherein a height of each spline of theplurality of splines tapers in a direction towards a port of the tubingportion.
 11. The connector of claim 2, wherein the channels areconfigured to contain a solvent therein, in the coupled configuration,the solvent is configured to bond the external surface of the tubing tothe inner circumferential surface of the tubing portion.
 12. Theconnector of claim 1, wherein: the body further comprises a restrictiondisposed between the tubing portion and the luer portion, therestriction including a first end, a second end and a projectionextending axially from the second end; and in the coupled configuration,the projection engages the tubing to create a seal between the secondend of the restriction and the tubing.
 13. A method of manufacturing theconnector of claim 1, comprising: providing a first core pin and asecond core pin, the first core pin comprising a first core pin bodyhaving a luer-shaping portion and a restriction-shaping portionconnected to each other, and the second core pin comprising a secondcore pin body having a base portion and a tubing-shaping portionconnected to each other, wherein a plurality of axially extending teethand axially extending recesses are formed along a radial exterior of thetubing-shaping portion; inserting the first core pin into a firstportion of a malleable material forming the luer portion of theconnector, and inserting the second core pin into a second portion ofthe malleable material forming the tubing portion of the connector, thefirst and the second core pins being axially aligned and inserted intothe malleable material from opposite ends; and contacting the axiallyextending teeth and axially extending recesses with the malleablematerial forming the tubing portion of the connector to define theplurality of splines and a plurality of recesses in the innercircumferential surface of the connector.
 14. The method of claim 13,wherein the first core pin further comprises a restriction-shapingportion at a distal end thereof, and the second core pin furthercomprises a radial projection-forming profile at a distal end thereof,the method further comprising: contacting the distal ends of the firstand the second core pins such the distal end of the first core pin is atleast partially received in a cavity at the distal end of the secondcore pin, and a spacing between the restriction-shaping portion and theradial projection-forming profile; and forming a radial projection inthe spacing between the restriction-shaping portion and the radialprojection-forming profile by filling the spacing with the malleablematerial.
 15. The method of claim 13, wherein a height of each of theaxially extending teeth ranges from about 0.0001 inches to 0.002 inches.16. A connector comprising: a body including: a tubing profile, a luerprofile axially opposite the tubing profile and connected thereto; arestriction interposed between the luer profile and the tubing profile,the restriction including a first end along the luer profile, a secondend along the tubing profile, and a projection extending axially fromthe second end; and an inner circumferential surface defining aninternal longitudinal bore in at least the tubing profile, theprojection extending into the internal bore; wherein: the innercircumferential surface further comprises a plurality of splinesextending linearly along a length of the inner circumferential surfacealong the tubing profile such that the plurality of splines extendsparallel with the internal longitudinal bore; the inner circumferentialsurface is configured to engage an external surface of a tubing in acoupled configuration; and in the coupled configuration, the projectiongrips the tubing to create a seal between the second end of therestriction and the tubing.
 17. The connector of claim 16, wherein theprojection is circularly disposed about a central axis of the internallongitudinal bore and configured to bite into the tubing to create theseal between the second end of the restriction and the tubing.
 18. Theconnector of claim 16, wherein: in the coupled configuration, edges ofthe plurality of splines grip and engage the external surface of thetubing to retain the tubing in the body.
 19. The connector of claim 18,wherein each pair of adjacent splines of the plurality of splines definea channel therebetween, each of the channels comprising a recessextending axially along a length of the inner circumferential surface.